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Focus on manufacturing practices and sterility issues

Device Regulation Alert: Safety, Compliance and Reimbursement News, May 21, 2007

FDA scrutiny of your manufacturing practices can hurt your bottom line and bring some bad PR. That's what happened to Shelhigh, Inc. whose implantable medical devices were seized by the FDA in April. The FDA alleged the manufacturer had a "poorly constructed" and "poorly contained" clean room, failed to monitor the manufacturing environment for microbial contaminants, didn't test sterility and contamination of products, and couldn't "scientifically support product expiration dates." The FDA still has to prove its case in court but in the meantime, Shelhigh faces the consequences of the seizure and some negative attention in the public and medical community.

Shelhigh issued a press release April 18 denying the FDA's claims and indicating it will challenge those claims in federal court. However, U.S. District Judge William J. Martini said during a hearing that he's "inclined to agree with the government interpretation, and not only their argument but based on my own reading of the law," reports The Star Ledger.

According to the FDA, Shelhigh didn't heed warnings following an inspection in the fall of 2006 that alerted the company to alleged manufacturing problems. Shelhigh contends that it has cooperated with the FDA and addressed warnings in a 2000 warning letter and sought verification of actions taken in response to a 2005 warning letter.

The bad news got worse for Shelhigh as the FDA recommended that physicians use alternative devices and watch their patients with Shelhigh implants and be alert to infections and proper functioning of the device. The FDA also issued in May a series of questions and answers about the seizure to respond to "interest from the medical community and the general public." Shelhigh responds to each of the FDA's comments on its own Web site.

To find out more, you can read the FDA's questions and answers and Shelhigh's responses to FDA claims.

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